MedPath

Pembrolizumab

Generic Name
Pembrolizumab
Brand Names
Keytruda
Drug Type
Biotech
CAS Number
1374853-91-4
Unique Ingredient Identifier
DPT0O3T46P
Background

Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.

Indication

Pembrolizumab is indicated for the following conditions:

For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.

Associated Conditions
Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated

First Posted Date
2025-04-03
Last Posted Date
2025-04-03
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
133
Registration Number
NCT06908993
Locations
🇫🇷

Montpellier - CHU, Montpellier, France

🇫🇷

Centre Antoine Lacassagne, Nice, France

🇫🇷

AP-HP Hôpital Cochin, Paris, France

and more 26 locations

PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients

Phase 2
Not yet recruiting
Conditions
Melanoma
Interventions
Drug: enfortumab vedotin
First Posted Date
2025-04-02
Last Posted Date
2025-04-27
Lead Sponsor
Grupo Español Multidisciplinar de Melanoma
Target Recruit Count
60
Registration Number
NCT06906822
Locations
🇪🇸

Hospital Virgen del Rocío, Sevilla, Spain

🇪🇸

Hospital General de Valencia, Valencia, Spain

🇪🇸

Institut Català D'Oncologia - Badalona, Badalona, Barcelona, Spain

and more 10 locations

Probiotics in Advanced Urothelial Carcinoma

Phase 2
Recruiting
Conditions
Probiotics
Advanced Urothelial Carcinoma
Immunotherapy
Interventions
First Posted Date
2025-04-01
Last Posted Date
2025-04-01
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
222
Registration Number
NCT06904573
Locations
🇨🇳

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China

🇨🇳

Sun yat-sen university cancer center, Guangzhou, Guangdong, China

🇨🇳

Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China

CtDNA to Predict Response to Chemo-Immunotherapy and Detect Minimal Residual Disease in Non-Small Cell Lung Cancer

Phase 2
Not yet recruiting
Conditions
Non Small Cell Lung Cancer
Interventions
Diagnostic Test: Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay
First Posted Date
2025-03-30
Last Posted Date
2025-03-30
Lead Sponsor
University of Miami
Target Recruit Count
30
Registration Number
NCT06902272
Locations
🇺🇸

University of Miami, Miami, Florida, United States

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Phase 3
Not yet recruiting
Conditions
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Metastatic Gastric Adenocarcinoma or Cancer
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Interventions
First Posted Date
2025-03-30
Last Posted Date
2025-05-14
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
500
Registration Number
NCT06901531

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Phase 3
Not yet recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2025-03-27
Last Posted Date
2025-05-06
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
686
Registration Number
NCT06899126

Intratumoral Vusolimogene Oderparepvec (VO) in Combination with Pembrolizumab for Angiosarcoma

Phase 2
Not yet recruiting
Conditions
Angiosarcoma, Adult
Angiosarcoma
Interventions
Biological: Vusolimogene Oderparepvec (VO)
First Posted Date
2025-03-27
Last Posted Date
2025-03-27
Lead Sponsor
Varun Monga, MBBS
Target Recruit Count
18
Registration Number
NCT06898970
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

Phase 1
Not yet recruiting
Conditions
Unresectable Hepatocellular Carcinoma
Interventions
First Posted Date
2025-03-26
Last Posted Date
2025-03-26
Lead Sponsor
Zhiyong Huang
Target Recruit Count
60
Registration Number
NCT06896396
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

Posaconazole Plus Pembrolizumab and Chemotherapy Vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-03-25
Lead Sponsor
Shandong Cancer Hospital and Institute
Target Recruit Count
20
Registration Number
NCT06802757
Locations
🇨🇳

Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China

A Prospective, Multicenter, Multicohort Phase II Study: Evaluating the Efficacy and Safety of Preoperative Neoadjuvant Treatment With a PD-1 Inhibitor in Combination With Chemotherapy in Locally Advanced Laryngeal and Hypopharyngeal Squamous Cell Carcinoma

Phase 2
Not yet recruiting
Conditions
Head and Neck Cancers
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-04-30
Lead Sponsor
Beijing Tongren Hospital
Target Recruit Count
180
Registration Number
NCT06894459
© Copyright 2025. All Rights Reserved by MedPath